Creating-Masterplan-for Dug-Warehouse-Transportation

PDF Edition - Creating a Master Plan for Drug Warehousing, Transportation and Distribution

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Did a truck driver just ruin a drug shipment?

Not only do you need to protect your drugs from tampering … you must shield your drugs from the extremes of heat and cold during transit … and store and dispense your products so they're as safe and effective as they were when they left the plant.

That means companies like yours need to begin NOW to create a master plan that establishes how your distribution chain will protect the integrity of your products, from the very beginning of your supply chain all the way to the customer’s doorstep.

These new requirements are complex, and creating your master plan will be no easy task. In the plan, you must address:

  • Infiltration of falsified medicinal products into your distribution chain or the theft of medicinal products from the chain. That means establishing security, access controls and mechanisms for securing products throughout your distribution process.
  • Regulating temperature and other environmental factors that your drugs are exposed to, even when they are in the control of third-party transport companies or warehouses. You must clearly spell out the controls placed on drugs with your contractors and third parties.
  • Ensuring that your drugs are distributed with appropriate speed, using firs- in first-out principles to deliver drugs well before expiration.
  • Ensuring that everyone in your distribution chain is adequately trained on implementing the requirements of the distribution master plan.
  • Ensuring that your intermediate storage solutions — customs warehousing or weekend, temporary warehousing — do not violate the conditions under which products must be maintained.
  • Assuring that all equipment and facilities used in shipment are of appropriate size and properly equipped to fulfill the requirements.
  • Ensuring that any software, equipment and processes used in transporting or distributing finished products, or monitoring their transport, are appropriately qualified and validated.
  • Establishing how recalls and complaints will be handled by your transport partners.
  • Setting SOPs for how your partners will handle all their responsibilities, including dealing with key issues such as variations from protocol, CAPA investigations and change control.
  • Documenting all distribution controls so that they are prepared for scrutiny by inspectors.
  • Auditing and conducting spot checks on your systems and your vendors to maintain compliance.

There's no denying that it's going to be an incredible amount of work to create and manage your master plan. That's why the editors of FDAnews have developed Creating a Master Plan for Drug Warehousing, Transportation and Distribution.

This report is the ultimate guide to preparing your company for compliance with Good Distribution Practice (GDP). Step by step, it walks you through the planning and implementation process, including the six key requirements included in the EU’s GDP guidelines:

  1. Procurement, storage, delivery and export of medicinal products in conformity with GDP
  2. Definition of managerial competence and responsibility
  3. Shipment of medicinal products
  4. Prompt provision of documentation
  5. Documentation and follow-up on deviations
  6. Initiation of CAPA actions

With the EU rules already in place, enforcement will not be far behind. Now is the time to make sure your distribution master plan is in place and fully up to date. Order your copy of Creating a Master Plan for Drug Warehousing, Transportation and Distribution today.

What You Will Learn

  • The challenges to be faced in validating a global transport chain
  • The procedure for validating a cold chain
  • Aspects to consider in shipping by refrigerated trucks
  • What storage conditions apply for medicinal products requiring special conditions (frozen, refrigerated, ambient)
  • The transport requirements found in pharmacopoeias and relevant guidelines
  • The role risk management plays in transport
  • The risks that can occur during transport
  • How risks can be assessed and controlled
  • What is meant by active and passive temperature control
  • The requirements that air freight containers have to meet
  • The advantages and disadvantages of temperature loggers
  • Under what conditions RFID technology can be used
  • The opportunities that modern telematics systems offer
  • The features and tools an alarm system must have
  • The steps needed to qualify large-scale, actively temperature-controlled systems
  • Test conditions for operational and performance qualification
  • The responsibilities of a logistics service provider

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Table of Contents

  • Regulatory Principles: EU, U.S., Canada and WHO
  • Transport Conditions: Transport As Mobile Storage
  • Transport Vehicles and Transport Packaging
  • Modes of Transportation: Guidelines and Quality Standards for Land Transportation

View the entire TOC

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Meet the Authors

Christoph Frick is the head of pharmaceutical development at Kohlpharma in Germany. He has worked for years at Kohlpharma and other companies as the head of quality assurance, good manufacturing practice, good documentation practice, cool chain processes, risk management, qualification and validation, auditing, business development and regulatory affairs.

Nicola Spiggelkötter is a pharmaceutical consultant with years of experience in quality assurance and API sourcing, cold chain process optimization, audits, staff training and risk management.

Who Will Benefit

  • Pharmaceutical plant managers
  • Quality assurance managers
  • GDP managers
  • GMP managers
  • Supply chain managers
  • Cool chain and cold chain process managers
  • Product safety managers
  • Risk managers
  • Transportation managers
  • Regulatory affairs managers
  • Packaging managers and repackagers
  • Trucking managers
  • Air freight managers
  • Pharmacists

Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

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